Vacuum Myofascial Therapy Device and Physical Activity for the Treatment of Chronic Non-specific Low Back Pain. A Single Blind Randomized Clinical Trial

Not Applicable

Completed

• Conditions: Chronic Nonspecific Low Back Pain
• Interventions: Other: Physical activity program.; Procedure: Vacuum myofascial therapy and physical activity program.

• Registration Number: NCT04534179
• Lead Sponsor: University of Cadiz

Brief Summary

The term non-specific low back pain refers to the painful symptoms located in the lumbar region, which is delimited between the lower margin of the ribs and the lower limit of the buttocks

Detailed Description

This study aimed to investigate the efficacy of a vacuum myofascial therapy device (VT) for improving pressure pain thresholds (PPTs), functionality, range of motion (ROM), low back pain-related disability, pain, and quality of life in patients with non-specific low back pain. Methods: A randomized controlled trial in which participants with non-specific low back pain (NP) were randomly assigned to either an experimental (VT) or a comparison physical therapy program (PTP) group.

Study Timeline

• Study First Submitted: 2020-08-17
• Study First Submitted QC: 2020-08-31
• Study Start: 2020-09-01
• Study First Posted: 2020-09-01
• Primary Completion: 2020-12-15
• Study Completion: 2021-01-15
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-16
• Last Update Posted: 2022-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Patients diagnosed of Chronic Nonspecific Low Back Pain that do not improve with conventional physiotherapy or pharmacological therapy protocols.
• Subjects who are in an active state of pain

Exclusion Criteria

• Individuals who have received surgery intervention in the spine
• Individuals have received the proposed treatment in one month´s period previously.
• Individuals who suffering from fibromialgia síndrome, cardiac patients with pacemakers, cancer, infectious processes, or generalized lymphedema.
• Pregnant women can not receive this treatment intervention.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physical activity Program	Physical activity program.	The exercise protocol would last 5 weeks, performing 3 exercise sessions per week, with an effective work time of 30 minutes per session. The exercises would be directly focused on activating the core stabilizing muscles.
Vacuum myofascial therapy and physical activity	Vacuum myofascial therapy and physical activity program.	The protocol would last 5 weeks, group received fifteen 30-minute sessions of vacuum myofascial therapy and fifteen sessions physical activity program similar to the control group per week.

Primary Outcome Measures

Name	Time	Method
The intensity of pain: 10-point Numerical Pain Rating Scale	Baseline	A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patients' current level of shoulder pain, and the worst and lowest level of pain experienced in the preceding week in the shoulder area. The minimal clinically important difference (MCID) for the NPRS in patients with shoulder pain was 1.1 points (Mintken, Glynn, and Cleland 2009).

Secondary Outcome Measures

Name	Time	Method
Active range of motion of the lumbar spine	Baseline , immediately after treatment, four and twelve weeks	Measured by a two branches goniometer
The intensity of pain: 10-point Numerical Pain Rating Scale	Immediately after the intervention , four and twelve weeks	A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patients' current level of lumbar pain, and the worst and lowest level of pain experienced in the preceding week in the lumbar area.
Pressure pain thresholds in trigger points	Baseline, immediately rafter treatment, four and twelve weeks	Pressure pain thresholds (PPTs) will be measured with a pressure algometer (Baseline, Pain TestTM, Wagner Instruments). The clinimetric properties of this instrument have been evaluated previously. The PPT will the point at which pressure elicited pain and will presented as kilograms per square centimeter. All measurements will be conducted by the same well-trained physician.
Questionnaire SF 12	Baseline, immediately after treatment, four and twelve weeks	The multidimensional health related quality of life
Roland Morris Disability Questionnaire	Baseline, immediately after treatment, four and twelve weeks	Roland Morris is a 24-item self-report questionnaire about how low-back pain affects functional activities
OSWESTRY LOW BACK PAIN DISABILITY QUESTIONNAIRE	Baseline, immediately after treatment, four and twelve weeks	The Oswestry Low Back Pain Disability Scale is a self-administered questionnaire, specific for low back pain, that measures limitations in daily activities.

Trial Locations

Locations (1)

Policlínica Santa María; 🇪🇸 Cádiz, Spain